Status:
COMPLETED
Sorafenib Maintenance Therapy for Patients With AML After Allogeneic Stem Cell Transplant
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Dana-Farber Cancer Institute
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
Sorfenib works by slowing the spread of cancer cells. It has been used in other studies for patients with AML with the FLT3-ITD mutation and information from these studies suggests that sorafenib may ...
Detailed Description
Subjects will taken sorafenib orally either once or twice daily. Subjects will come to the Bone Marrow Transplant Clinic 3 times (on Day 8, 15, and 30) during the first month of treatment. After the f...
Eligibility Criteria
Inclusion
- Subjects with AML with the FLT3-ITD mutation who have undergone allogeneic HSCT
- Peripheral blood chimerism studies showing \>/= 70% of all cells are of donor origin
- Adequate hematologic and hepatic function
- ECOG performance status 0-2
- Able to swallow whole pills
Exclusion
- Evidence of relapsed/recurrent/residual disease as assessed by bone marrow aspirate and biopsy performed between days 30-60 after HSCT
- Active acute graft vs host disease requiring an equivalent dose of \> 0.5 mg/kg/day of prednisone or equivalent or those patients which necessitated the addition of another agent for the treatment of GVHD beyond corticosteroids
- Ongoing uncontrolled infection
- Cardiac disease: congestive heart failure \> class II NYHA, unstable angina or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months
- Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
- Uncontrolled hypertension
- Known HIV infection or chronic hepatitis B or C
- Thrombotic or embolic events such as cerebrovascular accident including transient ischemic attacks within the past 6 months
- Pulmonary hemorrhage/bleeding event \> CTCAE v 4.0 Grade 2 within 4 weeks of starting study drug
- Any other hemorrhage/bleeding event \> CTCAE v. 4.0 Grade 3 within 4 weeks of starting study drug
- Serious non-healing wound, non-healing ulcer, or bone fracture
- Evidence or history of bleeding diathesis or coagulopathy
- Major surgery or significant traumatic injury within 4 weeks of starting study drug
- Use of St. John's Wort or rifampin (rifampicin)
- Known or suspected allergy to sorafenib
- Pregnant or breast-feeding
- Receiving any other investigational agents
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01398501
Start Date
August 1 2011
End Date
August 1 2016
Last Update
March 22 2017
Active Locations (2)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02214